Field of the Invention
The present invention relates to peptides having an influence on human and animal immune response, particularly the amplification of immune response, to compositions containing such peptides, and to methods of purifying and preparing such peptides in a pharmaceutically acceptable form. The invention also includes the use of such peptides to influence immune response.
In a number of diseases or other pathological conditions, the immune system response of the human or animal subject is depressed. As a result the subject becomes more susceptible to opportunistic infections, malignancies, or other pathological conditions against which a normal immune system would have protected the subject. Among the pathological conditions that depress the immune system are Acquired Immune Deficiency Syndrome (AIDS) and AIDS-related complex (ARC). Chemotherapy and aging are also associated with immune deficiency.
The inventor has discovered that leukocyte dialysates contain immunomodulators, which are materials or substances having therapeutic utility, as described in detail in U.S. Pat. No. 4,468,379. The U.S. Pat. No. 4,468,379 discloses a process for extracting such substances and methods of using them, as well as compositions containing immunomodulators. Other processes are disclosed in pending U.S. application Ser. No. 643,724. In general, immunomodulators have the property of modulating the response of a subject's immune system to antigens to which the subject's system has been previously exposed. Amplifier immunomodulators, or amplifiers, amplify or accelerate immune response. Suppressor immunomodulators, or suppressors, suppress immune response. The U.S. Pat. No. 4,468,379 and the U.S. application Ser. No. 643,724 disclose materials extracted from human and animal leukocyte preparations, with molecular weight (M.W.) generally below 3500. (An exception is a material designated L-suppressor, which appears to have a much greater M.W.) The chemical structure of these materials is not disclosed, although various properties of the materials are disclosed (such as elutability characteristics.)
It is not known at this time whether the immunomodulating properties of the materials described in the U.S. Pat. No. 4,468,379 and the U.S. application Ser. No. 643,724 are attributable to their containing molecules with the structures described hereinafter. It is the inventor's present hypothesis that the molecules and structures described hereinafter are a portion of the immunoamplifiers described in the U.S. Pat. No. 4,468,379 and the U.S. application Ser. No. 643,724, but not the entire active portion thereof.
A general discussion of the same field as that of this invention may be found in Kisfaludy et al. U.S. Pat. No. 4,428,938, "Peptides affecting the immune regulation and a process for their preparation", issued Jan. 31, 1984. That patent mainly concerns peptides of the form X-Arg-Lys-Y, where X may be null or Glp, and Y may be Asp, Asp plus other aminos, or several aminos terminated by Val. The U.S. Pat. No. 4,428,938 does not disclose peptides consisting of or containing the sequence Tyr-Gly-Gly. The U.S. Pat. No. 4,428,938 also covers salts, amides, lower alkyl esters and protected derivatives of the designated peptides.
Meienhofer U.S. Pat. No. 4,426,324, "Immunopotentiating peptides," issued Jan. 17, 1984, is also directed to the field of this invention. It discloses peptides of the form X-Glu-Asn-OH, and claims such peptides together with the pharmaceutically acceptable salts thereof. The U.S. Pat. No. 4,426,324 also does not deal with peptides consisting of or containing a Tyr-Gly-Gly triplet.